The following data is part of a premarket notification filed by Cynosure, Inc with the FDA for Picosure Workstation.
| Device ID | K160480 |
| 510k Number | K160480 |
| Device Name: | PicoSure Workstation |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cynosure, Inc 5 Carlisle Road Westford, MA 01886 |
| Contact | Amy Tannenbaum |
| Correspondent | Amy Tannenbaum Cynosure, Inc 5 Carlisle Road Westford, MA 01886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-22 |
| Decision Date | 2016-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494107246 | K160480 | 000 |
| 00841494106997 | K160480 | 000 |
| 00841494103583 | K160480 | 000 |